A nationwide collaborative research group, including Lecturer Mayuko Yamamoto from the Department of Clinical Medicine in the Faculty of Medical Sciences, contributed to the approval of canakinumab for Schnitzler syndrome.
Release Date:
Ilaris ® Solution for subcutaneous injection 150 mg Indications expanded to include Schnitzler's syndrome
― The findings that form the basis for this world-first expansion of indications were demonstrated in a physician-initiated clinical trial ―
Naoto Kobe, Associate Professor, Department of Dermatology, Graduate School of Medicine, Kyoto University; Satoshi Nakamizo, Specially Appointed Associate Professor, Department of Dermatology/Joint Research Course on Advanced Medical Infrastructure, Graduate School of Medicine, Kyoto University;Associate Professor Gen Yoshifuji, Department of Immunology and Rheumatology; Assistant Professor Tomoyasu Shiro, Department of Hematology/Laboratory Medicine and Cell Therapy Center; Lecturer Kazushi Izawa, Department of Pediatrics; and Professor Tokumitsu Inoue, Department of Molecular Genetics, Wakayama Medical University;a research group led by Nobuo Kanazawa, Chair Professor of Dermatology at Hyogo College of Medicine, in collaboration with Kyoto University Hospital, Kochi University Hospital (Mayuko Yamamoto, Lecturer, Department of Dermatology), the National Health Insurance Asahi Central Hospital (Shinichiro Kagami, Director of the Department of Allergy and Rheumatology, and Hiroshi Takemura, Director of the Department of Diabetes and Metabolism),and the Kanagawa Prefectural Police Friends Association Keiyu Hospital (Department of Dermatology, Director Yue Kawahara).Based on the results regarding efficacy and safety published in April and October 2025 in “Allergology International,” the English-language journal of the Japanese Society of Allergy, Novartis Pharma K.K. (hereinafter “Novartis”) submitted an application for an expanded indication in May 2025 and received approval for the expanded indication for Schnitzler’s syndrome on February 19, 2026.
While effective treatments for Schnitzer syndrome—which causes urticaria-like rashes, fever, and fatigue—are available overseas, they were not previously available in Japan. Consequently, physician-initiated clinical trials were conducted at multiple domestic institutions, and based on the results, a new indication was added—the first of its kind in the world.(© 2026 Naotomo Kambe. Image created with ChatGPT5.2)
[Press Release] Indication Expansion for Ilaris® 150 mg Subcutaneous Injection for Schnitzler’s Syndrome
Title: Investigator-initiated, multicenter, single-arm, open-label study of the effectiveness of canakinumab in Japanese patients with Schnitzler syndrome.
(An investigator-initiated, multicenter, single-arm, open-label study evaluating the efficacy of canakinumab in Japanese patients with Schnitzler syndrome)
Authors: Kambe N, Yamamoto M, Takemura K, Kagami SI, Kawahara Y, Yoshifuji H, Jo T, Izawa K, Nakamizo S, Inoue N, Ito T, Amino Y, Ibi Y, Morita S, Kanazawa N.
Publishedin: Allergology International (English-language journal of the Japanese Society of Allergology) . 2025; 74(2): 254-262.
DOI: 10.1016/j.alit.2024.10.001.
Title: Neutrophils predominate as IL-1β-expressing cells in Schnitzler syndrome: Insights from the SCan study evaluating the efficacy and safety of canakinumab in Japanese patients.
(Neutrophils are the primary IL-1β-expressing cells in Schnitzler syndrome: Insights from the SCan study evaluating the efficacy and safety of canakinumab in Japanese patients)
Authors: Kambe N, Inoue N, Ueki Y, Zhou Y, Yonekura S, Katsuo K, Nakamizo S, Tsujimoto H, Ohtani K, Yoshifuji H, Jo T, Izawa K, Yamamoto M, Takemura K, Kagami SI, Kawahara Y, Amino Y, Ibi Y, Morita S, Kanazawa N.
Publishedin: Allergology International (English Journal of the Japanese Society of Allergology). 2025; 74(4): 605-615.
DOI: 10.1016/j.alit.2025.04.003.